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Year: 2024

Windtree Announces Istaroxime Cardiogenic Shock Patent Filings In Countries Around the World

WARRINGTON, Pa., Oct. 23, 2024 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced that the Company has completed national phase filings of patent applications around the world, including in the United States, Germany, France, Italy, Japan and China. The istaroxime patent is entitled, “ISTAROXIME-CONTAINING INTRAVENOUS FORMULATION FOR THE TREATMENT OF PRE-CARDIOGEN1C SHOCK AND CARDIOGENIC SHOCK”, is No. PCT/US2023/018998 and was assigned application No. 18/858,086.      “Windtree continues to prepare for the potential of istaroxime in treating cardiogenic shock patients by expanding and strengthening our patent estate,” said Craig Fraser, Chairman...

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Envoy Medical to Present at the LD Micro Main Event XVII

WHITE BEAR LAKE, Minnesota, Oct. 23, 2024 (GLOBE NEWSWIRE) — Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a hearing health company focused on fully implanted hearing systems, today announced that David R. Wells, Chief Financial Officer, will present a corporate overview at the LD Micro Main Event XVII. The conference is being held on October 28 – 30, 2024 at the Luxe Sunset Boulevard Hotel in Los Angeles. Event:                                                  LD Micro Main Event XVII Presentation Date:                            Tuesday, October 29, 2024 Time:                                                   12:00 PM Pacific Time Register to watch presentation:       https://me24.sequireevents.com/ Mr. Wells will be available for one-on-one meetings with registered investors of the conference. About the Esteem® Fully...

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Achieve Life Sciences President and CMO, Dr. Cindy Jacobs, Speaks at FDA and NIH Smoking Cessation Public Meeting

SEATTLE and VANCOUVER, British Columbia, Oct. 23, 2024 (GLOBE NEWSWIRE) — Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for the treatment of nicotine dependence, announced that Dr. Cindy Jacobs, Achieve’s President and Chief Medical Officer, presented at the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) Joint Public Meeting on “Advancing Smoking Cessation: FDA and NIH Priorities” held on October 21, 2024. The public meeting was initiated by Robert Califf, M.D., who currently serves as the 25th Commissioner of the FDA. The meeting included other representatives from the FDA, the NIH, the National Institute on Drug Abuse, and key academic and industry organizations with the stated focus...

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Music Licensing, Inc. (OTC: SONG) Corrects ROI to 110.43% on 30-Year Royalty Stream Deal Involving Works by Miley Cyrus, Elton John, Lil Nas X, and XXXTENTACION, While Retaining Lifetime Ownership Rights

Naples, FL, Oct. 23, 2024 (GLOBE NEWSWIRE) — Music Licensing, Inc. (OTC: SONG), a leader in the acquisition and management of music royalties, is issuing a correction regarding the financial performance of its recent sale of a 30-year royalty stream, which includes works by major artists such as Miley Cyrus, Elton John, Lil Nas X, and XXXTENTACION. The company initially reported a return on investment (ROI) of 106.04%. Upon recalculation, the correct ROI is 110.43%, following the receipt of additional royalty payments. Music Licensing, Inc. has received royalty payments totaling $36,489 USD since acquiring the rights to these works on November 23, 2023, alongside $140,200 USD generated from the sale of the 30-year royalty stream. With an initial acquisition cost of $160,000 USD, the company’s recalculated ROI demonstrates even...

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Humacyte to Host Virtual KOL Event on the Use of Acellular Tissue Engineered Vessel (ATEV™) for AV Access in Hemodialysis on October 31, 2024

DURHAM, N.C., Oct. 23, 2024 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that it will host a virtual KOL event on Thursday, October 31, 2024 at 8:00 AM ET. To register, click here. The event will feature Charles Keith Ozaki, MD (Brigham and Women’s Hospital), Mohamad Anas Hussain, MD, PhD (Brigham and Women’s Hospital), and Timmy Lee, MD, MSPH (University of Alabama at Birmingham), who will discuss the current treatment landscape and unmet need for improved arteriovenous (AV) access in hemodialysis patients. During the event, the surgeons will share case studies and highlight the V007 Phase 3 clinical results for Humacyte’s acellular tissue engineered vessel (ATEV) product candidate...

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PharmaTher Receives Complete Response Letter from the U.S. Food and Drug Administration for Ketamine Abbreviated New Drug Application

TORONTO, Oct. 23, 2024 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL), dated October 22, 2024, for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024. The deficiencies cited in the CRL are classified as MINOR. The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. The FDA did not express concern about the stability of the ketamine submission batches, which achieved 18 months of stability without issue, and no new preclinical and clinical studies were...

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LifeMD® Launches TestoRx, a New Rex MD® Direct-to-Consumer Testosterone Replacement Therapy Telehealth Offering

Broadens Rex MD’s Platform with a Comprehensive Program for Treating Male Hypogonadism NEW YORK, Oct. 23, 2024 (GLOBE NEWSWIRE) — LifeMD, Inc. (Nasdaq: LFMD), a leading provider of virtual primary care services, announces the launch by its Rex MD men’s health brand of TestoRx, a new direct-to-consumer men’s hormone therapy telehealth offering. TestoRx offers an initial consultation with requisite blood tests to pre-screen patients, with treatment options that include both replacement therapy and alternative treatments to enhance endogenous hormone production – alongside ongoing telehealth visits and follow-up care. Rex MD is a leading men’s telehealth platform that offers access to virtual medical treatment for a variety of men’s health needs including erectile dysfunction, premature ejaculation, hair loss and, most recently, weight...

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electroCore to Announce Third Quarter September 30, 2024 Financial Results on Wednesday, November 13, 2024

ROCKAWAY, N.J., Oct. 23, 2024 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced that it will report financial results for the third quarter ended September 30, 2024, after the close of the market on Wednesday, November 13, 2024. Management will host a conference call and webcast at 4:30 PM EST to discuss the financial results and answer questions. Wednesday, November 13, 4:30 PM ESTDial-In:  877-407-8835 / +1 201-689-8779Conference ID: 13744121Webcast:  electroCore Earnings Webcast About electroCore, Inc.electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices...

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Worksport ltd. Announces Production of AL4 Premium Tonneau Cover, Signaling Major Growth Potential

Figure 1:Worksport’s AL4 Featuring Full Bed Access.Company Targets Significant Revenue Surge in 2025 with High-Demand AL4 Cover Poised to Revolutionize the $4 Billion Tonneau Cover Market West Seneca, New York, Oct. 23, 2024 (GLOBE NEWSWIRE) — Worksport Ltd. (NASDAQ: WKSP) (“Worksport” or the “Company”), a U.S.-based manufacturer and innovator of hybrid and clean energy solutions for the light truck, overlanding, and global consumer goods sectors is thrilled to announce a targeted market release of its highly anticipated AL4 Premium Tonneau Cover on December 15th, 2024. The Company has already begun manufacturing production-ready samples for testing and customer evaluation. Engineering staff at the Company’s state-of-the-art factory are finalizing the custom production lines required to produce large volumes of the new...

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Lumos Pharma Enters into Definitive Merger Agreement with Double Point Ventures to Go Private via a Tender Offer of $4.25 Cash per Share Plus Contingent Value Rights (CVR)

Lumos Pharma and the FDA Align on Final Design for Global, Double-blinded, Placebo-Controlled Phase 3 Trial Evaluating Oral LUM-201 in PGHD AUSTIN, Texas, Oct. 23, 2024 (GLOBE NEWSWIRE) — Lumos Pharma, Inc. (NASDAQ:LUMO) (“Lumos Pharma” or the “Company”), a clinical stage biopharmaceutical company focused on therapeutics for rare diseases, announced today that the Company has entered into a definitive merger agreement, dated October 22, 2024 (the “Merger Agreement”) whereby Double Point Ventures LLC (“DPV”) will acquire 100% of Lumos Pharma’s outstanding shares of common stock for $4.25 per share in cash, plus one non-transferable, unsecured Contingent Value Right (“CVR”) per share payable on achievement of certain milestones (the “Offer”). Following a thorough review of financing and strategic alternatives, Lumos Pharma’s Board...

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